MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included, no additional patient information was available.
Event or Problem Description
The customer observed elevated magnesium when processing on the architect c4000 processing module.A sample tested magnesium of 7.2 mg/dl but repeated 2.0 mg/dl.The customer normal reference range is 1.7 ¿ 2.2 mg/dl.No impact to patient management was reported.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer inspected the instrument, performed multiple troubleshooting procedures including part cleaning, replacement, and calibration but was unable to determine a single part as the cause of the result issue; therefore, the architect c4000, serial number (b)(6) was considered the probable contributor to the issue.Instrument service history was reviewed and found no additional complaints associated with discrepant/erratic patient results.A review of manufacturing documentation did not identify any nonconformances or potential nonconformances related to the current issue.A review of tracking and trending did not identify any trends for the architect c4000 and complaint issue.Labeling was reviewed and adequately addressed the issue.Based on the investigation, there was no systemic issue or deficiency identified for the architect c4000 analyzer, (b)(6).
Event or Problem Description
The customer observed elevated magnesium when processing on the architect c4000 processing module.A sample tested magnesium of 7.2 mg/dl but repeated 2.0 mg/dl.The customer normal reference range is 1.7 ¿ 2.2 mg/dl.No impact to patient management was reported.No impact to patient management was reported.

• Brand Name: ARCHITECT C4000 PROCESSING MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 25204395
• Report Number: 3016438761-2026-00276
• Device Sequence Number: 10097021
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02P24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CC MAGNESIUM (1000T), 03P68-24,; CC MAGNESIUM (1000T), 03P68-24,
• Patient Sex: Unknown